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Dexcom’s latest innovation in glucose monitoring, the Stelo continuous glucose monitor (CGM), has received clearance from the U.S. Food and Drug Administration (FDA), marking a significant milestone in diabetes care. The Stelo CGM, Dexcom’s first-ever over-the-counter glucose monitor patch, is set to revolutionize how patients with Type 2 diabetes manage their condition.
Designed for patients with Type 2 diabetes who do not use insulin, the Stelo CGM offers real-time glucose tracking without the need for a prescription. This accessibility breakthrough means that individuals without insurance coverage for CGMs can now benefit from Dexcom’s advanced monitoring technology.
The Stelo CGM, worn on the upper arm, provides up to 15 days of continuous monitoring before requiring replacement. Unlike traditional CGMs, Stelo is tailored specifically to the needs of Type 2 diabetes patients, offering a simpler experience with fewer alerts and notifications. This streamlined approach aims to make glucose monitoring more accessible and user-friendly for a broader patient population.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, praised the FDA’s clearance of Stelo, emphasizing its potential to expand access to glucose monitoring devices without the involvement of healthcare providers. This move aligns with Dexcom’s mission to empower individuals to take control of their health and well-being.
Dexcom’s decision to launch Stelo as an over-the-counter product reflects its commitment to making glucose monitoring more accessible and affordable. By offering Stelo at an approachable cash pay price, Dexcom aims to ensure that individuals can quickly access this valuable health tool.
Jake Leach, chief operating officer at Dexcom, highlighted the personal significance of glucose monitoring, likening it to a “mirror into their body.” With Stelo, Dexcom aims to provide individuals with the insight they need to manage their diabetes effectively, ultimately improving their quality of life.
As Dexcom continues to demonstrate the benefits of Stelo, it anticipates broader adoption and potential coverage by insurance companies. This FDA clearance represents a significant step forward in Dexcom’s mission to transform diabetes care through innovation and accessibility.
Shares of Dexcom surged over 2% in extended trading following the announcement, underscoring the market’s enthusiasm for this groundbreaking advancement in glucose monitoring technology. With Stelo, Dexcom is poised to empower individuals with Type 2 diabetes to live healthier, more informed lives.